Expander-2 Trial: Randomized Study to Evaluate Safety & Efficacy of the Urocross® Expander System & Retrieval Sheath

Pivotal, prospective, multi-center, randomized, sham-controlled, blinded study

Inclusion criteria

• Subject has signed an informed consent form (ICF).
• Men ≥ 45 years.
• Symptomatic BPH with the following (all must be met):

• IPSS ≥ 13.
• Qmax ≤ 12 mL/sec on a voided volume of ≥ 125 mL.
• PVR < 250 mL.
• Prostate volume 30-80 cc measured by transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI) within 6 months prior to randomization.
• Subjects willing to be off their BPH-related medications from time of enrollment and throughout study participation.

Note: All subjects on BPH-related medications must start a washout period prior to qualifying questionnaires and uroflowmetry.

Exclusion criteria

Subjects who meet ANY of the following exclusion criteria will not participate in the trial:

• Previous BPH procedure intended to disobstruct the bladder outlet (e.g., prostate surgery, stent implantations, laser prostatectomy, hyperthermia or another invasive treatment to the prostate).
• Obstructive protruding (mobile) middle (median) prostatic lobe as confirmed by cystoscopy.
• High bladder neck as determined by the Investigator.
• Urethral stricture, meatal stenosis, or bladder neck contraction - either current, or recurrent requiring 2 or more dilatations.
• Biopsy of the prostate within past 8 weeks.
• Baseline Prostate Specific Antigen (PSA) level > 10 ng/mL or confirmed or suspected prostate cancer (subjects with a PSA level > 2.5 ng/mL or whose PSA levels fall outside age-specific or local reference ranges, should have prostate cancer excluded to the Investigator's satisfaction in conjunction with shared decision making [SDM] with the study subjects).
• Confirmed or suspected bladder cancer.
• History of cystolithiasis, kidney stone, or kidney disease within the prior 3 months.
• History of neurogenic bladder.
• Previous episode of AUR, i.e., post hernia repair or other condition or disease that might cause urinary retention.
• Parkinson's disease or other neurologic disease known to impact bladder function (e.g., stroke, TIA, multiple sclerosis).
• Serum creatinine > 1.8 mg/dL or renal dysfunction attributed to bladder outlet obstruction (BOO).
• Concomitant UTI (subject can be enrolled following successful treatment of UTI and a negative UTI test), or subjects who have a history of recurrent or chronic UTIs (defined as 2 or more UTIs in the past 12 months).
• Active infection including acute bacterial prostatitis.
• Previous pelvic irradiation or radical pelvic surgery.
• Known allergy to nickel.
• Subjects with life-threatening disease in which life expectancy is foreshortened are excluded.
• Desire to maintain fertility post-treatment.
• Anticipated need for additional major surgery or treatments for comorbidities during the study period (e.g., valve repair, organ transplant).
• Prostatic urethral length < 25 mm or > 60 mm, as measured from bladder neck to verumontanum, using cystoscopy just prior to randomization.
• Any concurrent medical condition or illness that might prevent study completion or that could impact the study results such as:

• severe cardiac arrhythmias uncontrolled by medications or pacemaker.
• congestive heart failure New York Heart Association (NYHA) III or IV.
• uncontrolled diabetes mellitus.
• significant respiratory disease in which hospitalization may be required.
• known immunosuppression (i.e., AIDS, post-transplant, undergoing chemotherapy).
• Inability to stop taking anticoagulants and/or antiplatelets for at least 3 days prior to the procedure or coumadin for at least 5 days prior to the procedure.

Note: Low dose aspirin therapy is acceptable.

• Unable or unwilling to complete all required questionnaires and follow-up assessments.
• Participating in any other investigational study for either drug or device which can influence collection of valid data under this study.
• Subject is in custody or institution, or, in the Investigator's opinion, has a physical, psychological, or medical impairment that might prevent study completion or would confound study results (including subject questionnaires).